| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00486-1 |
| Product Name/Description |
ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35)
ARTG Number: 139591 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/04/2014 |
| Responsible Entity |
|
| Reason/Issue |
The following issues may occur when using the stress echo feature:
- Shorter-than-expected clips may occur when using systolic-only captures with heart rates at approximately 120bpm (beats per minute) and higher. This computational error may occur at any heart rate; but the system produces a smaller error for lower heart rates. The issue may also cause the system to change from systolic-only captures to full beat (R-R).
- Intermittently, some post-exercise clips may not be captured during continuous capture acquisition.
- Post-exercise clips marked for deletion (unselected clips) may be restored to the study after cycling power to the system.
The potential risk to the patient may be a repeated stress echo study. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A software update will be provided to correct this problem.
End users are advised to avoid the potential risks associated with this issue by:
- Discontinue use of the stress echo feature with software version 3.5
- For studies acquired with the systolic only captures, review all patient studies on exams performed after the software revision 3.5 was installed. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |